TABLE 3.
Results of Baseline and Postrandomization Echocardiogram
| Normal Value | Baseline | Postrandomization | |||||
|---|---|---|---|---|---|---|---|
| ECCO2R Group (n = 13) | Usual Care Group (n = 8) | p | ECCO2R Group (n = 13) | Usual Care Group (n = 8) | p | ||
| Primary outcome | |||||||
| TAPSE, mean (sd), mm | ≥ 17 | 21.3 (3.7) | 19.5 (3.4) | 0.29 | 21.3 (5.4), n = 12 | 20.1 (3.2), n = 7 | 0.60 |
| Secondary outcome | |||||||
| Measures of RV function | |||||||
| Change in TAPSE, mean (sd), mm | 0.58 (4.1), n = 12 | 0.61 (5.4), n = 7 | 0.99 | ||||
| RV fractional area change, mean (sd), % | ≥ 35 | 44.9 (7.7), n = 8 | 41.3 (3.7), n = 4 | 0.40 | 44.8 (13.0), n = 9 | 45.3 (9.6), n = 6 | 0.93 |
| Right ventricular Tissue Doppler Imaging systolic excursion velocity, mean (sd), cm/s | ≥ 9.5 | 12.9 (2.0), n = 7 | 10.3 (0.6), n = 3 | 0.07 | 14.0 (3.7), n = 9 | 11.5 (1.3), n = 4 | 0.22 |
| RVOT VTI, mean (sd), cm | ≥ 19 | 16.4 (1.7), n = 9 | 16.0 n = 1 | NA | 17.9 (3.1), n = 9 | 11.8 (4.9), n = 3 | 0.027 |
| Acute cor pulmonale, n (%) | Absent | ||||||
| Absent | 8 (80.0) | 5 (83.3) | 0.87 | 8 (72.7) | 5 (71.4) | 0.95 | |
| Present | 2 (20.0) | 1 (16.7) | 3 (27.3) | 2 (28.6) | |||
| Measures of RV size | |||||||
| RVEDA, mean (sd), cm2 | 10–24 | 17.1 (3.2), n = 8 | 17.3 (3.1), n = 4 | 0.92 | 16.9 (2.9), n = 8 | 18.1 (4.8), n = 6 | 0.57 |
| RVEDA/LVEDA, mean (sd) | < 0.6 | 0.60 (0.19), n = 8 | 0.53 (0.04), n = 4 | 0.52 | 0.60 (0.17), n = 8 | 0.57 (0.16), n = 6 | 0.78 |
| Measures of RV afterload | |||||||
| TR severity, n (%) | Absent | ||||||
| Absent | 1 (11.1) | 4 (66.7) | 0.08 | 1 (10.0) | 2 (40.0) | 0.39 | |
| Mild | 7 (77.8) | 2 (33.3) | 6 (60.0) | 2 (40.0) | |||
| Moderate | 1(11.1) | 0 (0.0) | 3 (30.0) | 1 (20.0) | |||
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
| Tricuspid valve regurgitation velocity (maximum), mean (sd), m/s | ≤ 2.8 or not measurable | 2.7 (0.6), n = 6 | n = 0 | 2.6 (0.8), n = 6 | 2.5 (0.4), n = 3 | 0.73 | |
| RVOT AT, mean (sd), ms | > 105 | 112.3 (15.5), n = 7 | 120.0 (14.1), n = 2 | 0.55 | 101.0 (25.3), n = 9 | 124.3 (14.0), n = 3 | 0.17 |
| RVOT notching, n (%) | Absent | ||||||
| Absent | 7 (87.5) | 1 (100.0) | 0.71 | 7 (77.8) | 3 (100.0) | 0.37 | |
| Present | 1 (12.5) | 0 (0.0) | 2 (22.2) | 0 (0.0) | |||
| Right atrium area, mean (sd), cm2 | ≤ 18 | 14.6 (3.8), n = 9 | 15.1 (3.9), n = 4 | 0.83 | 15.3 (5.6), n = 9 | 14.3 (2.9), n = 5 | 0.70 |
| Measures of LV function | |||||||
| LV systolic function, n (%) | |||||||
| Normal | 7 (63.6) | 2 (33.3) | 0.08 | 8 (80.0) | 3 (42.9) | 0.10 | |
| Hyperdynamic | 1 (9.1) | 4 (66.7) | 1 (10.0) | 4 (57.1) | |||
| Mildly impaired | 2 (18.2) | 0 (0.0) | 1 (10.0) | 0 (0.0) | |||
| Moderately impaired | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
| Severely impaired | 1 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
LV = left ventricle, LVEDA = left ventricular end diastolic area, NA = not applicable, RV = right ventricle, RVEDA = right ventricular end diastolic area, RVOT = right ventricular outflow tract, RVOT AT = right ventricular outflow tract acceleration time, RVOT VTI = right ventricular outflow tract velocity time integral, TAPSE = tricuspid annular plane systolic excursion, TR = tricuspid regurgitation.
p values from t-test for continuous data or chi-square for categorical data.